EP0161471B1 - Récipient pour fluide contenant du bicarbonate - Google Patents

Récipient pour fluide contenant du bicarbonate Download PDF

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Publication number
EP0161471B1
EP0161471B1 EP85104160A EP85104160A EP0161471B1 EP 0161471 B1 EP0161471 B1 EP 0161471B1 EP 85104160 A EP85104160 A EP 85104160A EP 85104160 A EP85104160 A EP 85104160A EP 0161471 B1 EP0161471 B1 EP 0161471B1
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EP
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Prior art keywords
chamber
container
container according
bag
bicarbonate
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EP85104160A
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German (de)
English (en)
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EP0161471A3 (en
EP0161471A2 (fr
Inventor
Mariano Dr. Feriani
Stefano Dr. Biasioli
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Fresenius SE and Co KGaA
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Fresenius SE and Co KGaA
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Priority to AT85104160T priority Critical patent/ATE59774T1/de
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
    • B32B27/304—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/1668—Details of containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/1668—Details of containers
    • A61M1/167—Flexible packaging for solid concentrates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/287—Dialysates therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3455—Substitution fluids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2027—Separating means having frangible parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/724—Permeability to gases, adsorption
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/80—Medical packaging

Definitions

  • the invention relates to a container for providing a bicarbonate-containing dialysis, substitution or infusion liquid for peritoneal dialysis, hemofiltration or infusion, comprising a first container part that has an acid solution and a second container part that is blocked with the first container part, however flow connection part to be opened is connected and which is filled with a solution containing bicarbonate, one of the container parts having at least one outlet tube which is provided with a removable closure.
  • a dialysis fluid is introduced into the peritoneal space of the patient, this dialysis fluid having an electrolyte composition necessary for dialysis and having acetate or lactate ions as a buffer element for the treatment of metabolic acidosis.
  • this dialysis fluid is also weakly acidic and inhibits the antimicrobial bodies present in the peritoneum, so that the introduction of such solutions into the peritoneal space must be carried out under strictly sterile conditions, since otherwise there is a risk of peritonitis.
  • bicarbonate-containing dialysis fluid is known, for example, from EP-A-22 922, which is produced by mixing an acid concentrate with a bicarbonate concentrate with the addition of water. Two concentrates must be used insofar as there is a risk that the reaction of calcium ions with carbonate ions will precipitate insoluble calcium carbonate, which is no longer available for physiological needs.
  • TS Ing et al in Int. J. Artif. Organs 1981, pp. 308, 309 and 1983, pp. 217, 218 proposed the online production of a bicarbonate-containing dialysis fluid for use in peritoneal dialysis, wherein an acidic solution and a basic solution were mixed and the dialysate product obtained therefrom was then fed to the patient becomes.
  • the basic solution which contains the Njb sodium bicarbonate, is always placed in a glass container, for example a glass bottle or a glass syringe, in which there is basically no risk that CO 2 separated from the bicarbonate during the storage period disappears due to diffusion.
  • the originally used solution containing bicarbonate remains completely in the glass vessel and can thus be used completely in the production of a dialysis liquid containing bicarbonate.
  • Ing et al have proposed a glass container for the use of the bicarbonate-containing solution, as is usually used to absorb mineral water saturated with C0 2 .
  • the invention is therefore based on the object of developing the container of the type mentioned at the outset in such a way that it can be used without problems in CAPD, hemofiltration or infusion without the risk that the composition of the bicarbonate-containing solution changes practically.
  • the object is achieved in that the first container part and the second container part are provided in an organic polymer bag arrangement having at least two chambers.
  • the container according to the invention can be used for long-term storage of bicarbonate-containing solutions, ie there is practically no risk that the CO 2 released by the decomposition of bicarbonate will diffuse appreciably through the polymeric wall of the bag. This is surprising insofar as it was previously generally assumed that either thick-walled plastic containers or gas-tight glass containers had to be used in order to form an effective diffusion barrier against the released C0 2 .
  • a bag for a bicarbonate-containing solution can now be used for the first time, which has sufficient long-term stability, that is to say can store the originally used bicarbonate solution without decomposition at least approximately in a year.
  • the invention Use the bag arrangement particularly advantageously with the CAPD, since the dialysis liquid containing bicarbonate can be produced immediately before the introduction into the peritoneal space and the entire bag arrangement can then be carried comfortably on the patient's body.
  • At least two container parts or compartments are provided in the container according to the invention, which are connected to one another via a flow connection part.
  • This flow connection part is usually tubular and can be either rigid or flexible in nature.
  • the flow connection part is rigid, a plastic tube made of a rigid material is usually selected, which is connected at its ends to the two container parts.
  • a connecting part can also be completely surrounded by the plastic material of the two compartments, which is particularly advantageous.
  • a flexible piece of pipe for example in the form of a piece of hose, can be used, which is connected to the respective container parts, for example by welding.
  • a flexible piece of hose like the rigid flow connection part, can be connected either completely or partially to the respective plastic material of the two container parts.
  • the flow connection part mentioned above is closed before the two solutions in the container parts are mixed.
  • the flow connection part is provided with a shut-off element which is opened or removed in use.
  • shut-off device is, for example, the commonly used break-off parts in the rigid embodiment which close a tubular part and can be broken off from this tubular part in use along a line of weakness.
  • this is a shut-off element integrally connected to the two container parts, which is advantageously provided on the flow connection part, which is also integrally connected to the two container parts.
  • the flow connection part can of course also be provided with a barrier wall, which is destroyed if necessary, so that the flow connection is thereby established.
  • a tube made of a rigid plastic material can in turn be provided between the two container parts, the flow opening of which is closed with such a wall made of the same plastic material.
  • this barrier wall is pierced by a suitably designed opening device, for example a spike, whereby the flow connection between the two parts of the bag is established.
  • the flow connection part can also be closed by a closure device which shuts off the flow connection part by means of frictional engagement, for example in the form of an elastic stopper.
  • a closure device which shuts off the flow connection part by means of frictional engagement, for example in the form of an elastic stopper.
  • Such a closure is to be used in particular in the container part in which a certain excess pressure can prevail.
  • the stopper will therefore be inserted into the flow connection part from the side of the container part which contains the bicarbonate solution.
  • a connecting piece made of a rigid plastic for example polycarbonate and the like
  • a connecting piece made of a soft plastic material for example soft PVC or polyethylene and the like
  • a rigid plastic shut-off part can also be provided integrally or by frictional engagement in the flexible flow connection part, which - as mentioned above - has a break-off part which is broken off to mix the two solutions.
  • Integral melting of a rigid piece of pipe is particularly preferred.
  • This closure part described below as a break-off part, is advantageously provided in a two-chamber bag arrangement, in which the two chambers are provided in a one-piece bag and are separated from one another by a weld seam. The break-off part is inserted into this weld seam and thus creates a flow connection between the two chambers after the break-off part has been destroyed.
  • Such a two-chamber bag is produced by welding two plastic films together along an outer edge, leaving fill slots or slots for receiving a drain hose, and additionally welding a weld across the bag, dividing the bag into a first and a attaches second chamber, a flow connection part is inserted into this transverse weld.
  • the fillers to be stored are poured into the chambers into which fillers may be welded, if necessary.
  • the filler slots or filler neck are then welded off, ie the chambers are sealed off from the atmosphere. It is ensured beforehand that the drain hose is also closed.
  • Organic polymers with a low water vapor permeability or carbon dioxide permeability are used as the bag material.
  • Polymers that can be used include polyethylene, polypropylene, PVC, polyvinylidene chloride, polymethyl methacrylate, and copolymers and copolymers, for example ethylene / propylene plastics, poly (ethylene / vinyl acetate), acrylonitrile / butadiene / styrofoam polymers, ethylene / propylene block copolymers, styrene copolymers and the like. the like
  • PVC polystyrene resin
  • organic-based plasticizers for example dioctyl phthalate.
  • Bag materials that come into contact with the solutions are preferably polyethylene and PVC.
  • the polymer used as a bag film can be coated on the outside with one or more layer (s) reducing these permeabilities in the form of a laminate.
  • a metal foil or another polymer for example polyamides, PVC, polyvinylidene chloride, polyvinyl fluoride, polytrifluorochloroethylene, polyethylene terephthalate, polyester and the like, can be used as such a laminate layer on the bag film, for example.
  • Polyamide, polyvinylidene chloride, polyethylene terephthalate and polyester are preferred.
  • the polymeric outer and inner foils are advantageously glued together by means of a laminating adhesive, such as polyvinylidene chloride or polyurethane, and are then available as laminates ready for use.
  • a laminating adhesive such as polyvinylidene chloride or polyurethane
  • Preferred laminates generally have a water vapor permeability according to DIN 53 122 of ⁇ 1 at room temperature and a relative atmospheric humidity of about 85%.
  • Such values apply to standard foils with a thickness of 50-100 ⁇ m, in particular approximately 75 ⁇ m for the inner foil and 20-100 ⁇ m, in particular 30-70 ⁇ m for the lamination foil serving as the outer foil.
  • the carbon dioxide permeability is reduced in the preferred laminates, this value being below 20 cm 3 /, 2 x day x bar pressure difference.
  • a polyethylene with medium to high density is used as the inner film, which is usually produced by low-pressure polymerization.
  • the density is in a range of 0.91-0.94, in particular about 0.935 g / cm 3.
  • This polyethylene can be used without difficulty at the sterilization temperature of about 115-125 ° C.
  • this polyethylene is advantageously laminated with a polyamide film in the strengths mentioned above.
  • Such films are sold for example under the name "Flexovac V 7144" by Sengewald, Halle / Westf., BR Germany, for medical purposes.
  • an outlet tube made of a copolymer of ethylene and vinyl acetate (EVA) is welded into this polyethylene inner film, which is then cross-linked by high-energy radiation and can thereby be used without destruction while maintaining its elastic properties at the aforementioned sterilization temperatures.
  • EVA vinyl acetate
  • the flow connection part can also consist of cross-linked EVA if a resilient polymer is to be used.
  • PVC can be used, which is the usual bag material for medical purposes.
  • PVC hose pieces can be welded into such a bag both as a flow connection part and as an outlet hose.
  • this PVC inner film can be laminated with an outer film, the material of which has been mentioned above, in order to reduce or permeability to water vapor and C0 2 .
  • the entire bag arrangement including the drain line and the connector piece located on this drain line, is surrounded by a protective sheath made of a material which advantageously has a very low level Has CO 2 permeability.
  • This protective cover is advantageously made of a soft, transparent plastic, which is impenetrable to germs and can also be sterilized at at least 115-125 ° C. Between this protective cover, which replaces the outer layer of the aforesaid laminate, and the bag assembly according to the invention can advantageously be provided, gaseous C0 2 at a pressure such that the C02 partial pressure is compensated for in the bicarbonate-containing liquid, at least.
  • Such an arrangement is particularly preferred in those cases in which a conventional PVC bag, which has a wall thickness of approximately 0.4-0.6 mm, is used to hold the two liquids without lamination with an outer film.
  • Such protective covers are preferably used in the form of laminates, for example laminates made of polyester and polypropylene, polya mid and polypropylene or polyethylene terephthalate and polypropylene.
  • Such a protective cover consists of an upper web and lower web, which are welded at the edges to form a bag. If necessary, one or both of the webs can be deep-drawn according to the shape of the bag to be protected, as described in EP-A-50255, the disclosure of which is expressly incorporated by reference.
  • such a protective cover if it is made of a material that has a very low CO 2 permeability, can also be evacuated in accordance with the method of the European patent specification and thus fit tightly against the protective bag. As a result, there is practically no gaseous V0 2 between the two bags.
  • a mixed material consisting of a plastic layer and a metal foil, for example an aluminum foil, can be used, which is practically CO 2 impermeable in the strengths used, so that C0 2 can only diffuse through the plastic welding points, which, however is essentially negligible.
  • the filling volumes of the two container parts are selected according to the intended use, the volume of each container part advantageously being able to vary from 0.5-2.5 liters.
  • the compartment receiving the final mixture advantageously has such a size that both liquids can be taken up together.
  • both liquids can also be mixed with one another by alternately pumping back and forth in the bag arrangement.
  • the acidic solution which contains the calcium and magnesium salts has the following concentration, expressed in meq (mEq) / l of water:
  • the solution containing bicarbonate has the following components in meq / 1 water:
  • sodium carbonate can also be used, the basic solution then having 120-128 meq / I carbonate and the acidic solution 60-64 meq / I HCI.
  • the acetic acid in the mixture reacts with the hydrogen carbonate to liberate 2-3 mmol / 1 CO 2 , which is physically dissolved in the mixture, whereby a certain excess pressure is created in the solution. This is dependent on the partial pressure Pco 2 and is approximately between 50-80 mm / Hg.
  • sodium carbonate If sodium carbonate is used as the basic agent, it reacts with the hydrochloric acid of the acidic solution to form C0 2 and hydrogen carbonate ions in approximately equal amounts. This amount of CO 2 can also be absorbed by the bag.
  • the bicarbonate-containing solution is also to be osmotically active, which is usually the case with solutions for CAPD, a certain amount of an osmotically active substance, for example glucose, is provided in the acidic solution.
  • the acidic solution contains about 26-90 g of glucose / l, which, when diluted 1: 1, leads to an osmolarity of the solution of about 350-550 mosm / l.
  • sodium bicarbonate is preferred over the use of sodium carbonate (soda).
  • the basic, bicarbonate-containing solution which has not yet been mixed with the acid solution, is placed in the compartment which has the drain line or hose.
  • This arrangement is to be preferred for safety reasons, since in outpatient dialysis, that is to say the patient himself, there may be a risk that a solution that has not yet been mixed gets through the drain line into the peritoneal space of the patient.
  • a bicarbonate The solution in the unmixed state can be tolerated by the patient without difficulty, whereas this is not the case with the acid solution.
  • the presentation of the bicarbonate solution in the compartment that is connected to the drain line is preferred.
  • the prior art cf. Ing. 1983 suggests filling a plastic bag with the acid solution, which is disadvantageous for safety reasons.
  • Fig. 1 shows a bag in side view, from Fig. 1 and 2, a container 10 can be seen, which is designed as a plastic bag.
  • This container 10 has two chambers, namely a first chamber 12 and a second chamber 14, which are separated from one another by a septum 16 in the form of a weld seam.
  • the bag 10 also has a welded edge zone 18, with which the two chambers 12 and 14 are closed off from the atmosphere.
  • This weld 18 is otherwise connected to the weld 16 so that there is no flow connection between the chambers with the exception of the flow connection part 20, which is inserted into the weld 16 and is surrounded by it.
  • the first chamber 12 is connected to a drain line 22, which is advantageously welded around the welding edge 18 and can establish a flow connection with the first chamber, provided that the shut-off device 24 which advantageously shuts off the drain line 22 is opened.
  • a drain line 22 which is advantageously welded around the welding edge 18 and can establish a flow connection with the first chamber, provided that the shut-off device 24 which advantageously shuts off the drain line 22 is opened.
  • This usually consists of a plastic tube with an attached break-off part, which is destroyed in use.
  • the flow connection part 20 consists of a hollow cylindrical part which merges into a further hollow cylindrical part with a smaller outside diameter and which is closed with a break-off piece along the line of weakness.
  • the first chamber 12 is advantageously filled with a liquid 34 which still has to be diluted, while the second chamber 14 is filled with an acid solution 36.
  • the break-off piece is broken off by the flow connection part 20, so that the acidic solution 36 can now flow through the flow channel 38 in the flow connection part 20 into the first chambers 12.
  • the shut-off device 24 is opened and the drain line 22 is thus released. At its other end, this is connected to a conventional connection device, not shown, for example a CAPD connector part, a catheter, infusion device and the like.
  • the container 10 has a welded suspension device 49 in the form of an eyelet at its upper end.
  • the solutions are filled into the chambers 12 and 14 through filling slots (not shown) in the welding rim 18, which are then welded shut. If necessary, a certain amount of gaseous CO 2 is added to the bicarbonate-containing solution in the first chamber 12, for example in order to generate an internal pressure of approximately 40-80 mm / Hg, in order to influence the decomposition equilibrium of the bicarbonate.
  • the container 10 can have an injection device (not shown) in the region of the first chamber 12, as is usually the case with the CAPD bags currently used.
  • Containers 10 were produced which contained 12 1500 ml of bicarbonate-containing solution in the first chamber and 14 500 ml of acid solution in the second chamber 14, for a total of 2 liters of bicarbonate solution. These filled two-chamber bags were sterilized in the usual manner at about 120 ° C. and then stored for more than 6 months, the unmixed solutions remaining stable and their chemical composition having not changed. Tests for sterility, pyrogens and particles, which were carried out on the unmixed and mixed solutions, were also negative. Furthermore, the glucose added to the acidic solution did not caramelize.
  • the mixed solution had the following composition in mval / l:
  • the solution contained 16.5 g / l glucose, which corresponds to an osmolarity of 369 mosm / l.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
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  • External Artificial Organs (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Package Specialized In Special Use (AREA)
  • Medicinal Preparation (AREA)

Claims (11)

1. Récipient pour la préparation d'un liquide de dialyse, de substitution ou de perfusion contenant du bicarbonate pour la dialyse péritonéale, l'hé- mofiltration ou la perfusion, comprenant une première partie de récipient qui contient une solution d'acide, et une deuxième partie de récipient, qui est raccordée à la première partie de récipient par un organe de raccordement d'écoulement fermé, mais pouvant être ouvert, et qui est remplie d'une solution contenant du bicarbonate, l'une des parties de récipient comprenant au moins un tube de sortie qui est muni d'un organe d'obturation amovible, caractérisé en ce que la première partie de récipient et la deuxième partie de récipient sont prévues dans un dispositif récipient (10) en polymère organique comprenant au moins deux chambres (12, 14).
2. Récipient suivant la revendication 1, caractérisé en ce que le récipient (10) est un poche à deux chambres, dont la première chambre (12) est séparée de la deuxième chambre (14) par un cloison (16).
3. Récipient suivant la revendication 2, caractérisé en ce que la cloison est formée par une ligne de soudure (16) établie transversalement sur la poche et dans laquelle est prévu un organe de raccordement d'écoulement (20) à ouvrir.
4. Récipient suivant la revendication 3, caractérisé en ce que le liquide contenant du bicarbonate (34) est contenu dans la première chambre (12), d'où part la conduite de sortie (22), et la solution d'acide (36) est contenue dans la deuxième chambre (14) du dispositif récipient (10).
5. Récipient suivant la revendication 1, caractérisé en ce que des polymères organiques ayant une faible perméabilité à la vapeur d'eau et une faible perméabilité au dioxyde de carbone sont utilisés comme feuille intérieure pour la poche à deux chambres.
6. Récipient suivant la revendication 5, caractérisé en ce que le polyéthylène ou le PVC sont utilisés comme feuille intérieure.
7. Récipient suivant la revendication 5, caractérisé en ce que la fueille intérieure est doublée d'une feuille extérieure avec formation d'un stratifié.
8. Récipient suivant la revendication 7, caractérisé en ce que des polyamides, le PVC, le poly-(chlorure de vinylidène), le poly(téréphtalate d'éthylène) ou des polyesters sont utilisés comme feuille extérieure.
9. Récipient suivant la revendication 8, caractérisé en ce que les stratifiés ont une perméabilité à la vapeur d'eau suivant DIN 53122 de 1 au maximum et une perméabilité au dioxyde de carbone de 20 cm3 par m2 par jour et par bar de différence de pression au maximum, la feuille intérieure a une épaisseur d'environ 50 à 100 um et la feuille extérieure, une épaisseur d'environ 20 à 100 um.
10. Récipient suivant la revendication 3, caractérisé en ce que l'organe de raccordement d'écoulement (20) comprend au moins un corps cylindrique creux fait d'une matière plastique dure, qui est raccordé par un ligne d'affaiblissement à une pièce à rompe.
11. Récipient suivant la revendication 1, caractérisé en ce que le dispositif récipient (10) est entouré d'un voile de protection en forme de poche.
EP85104160A 1984-04-06 1985-04-04 Récipient pour fluide contenant du bicarbonate Expired - Lifetime EP0161471B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT85104160T ATE59774T1 (de) 1984-04-06 1985-04-04 Behaelter fuer eine bicarbonathaltige fluessigkeit.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT8555484 1984-04-06
IT8555484A IT1214872B (it) 1984-04-06 1984-04-06 Sacca contenente due o piu'sostanze per infusione ad uso medicale, poste in scomparti separati, comprendente mezzi atti a consentire la miscelazione di tali sostanze solo al momento dell'uso.

Publications (3)

Publication Number Publication Date
EP0161471A2 EP0161471A2 (fr) 1985-11-21
EP0161471A3 EP0161471A3 (en) 1987-06-24
EP0161471B1 true EP0161471B1 (fr) 1991-01-09

Family

ID=11327999

Family Applications (1)

Application Number Title Priority Date Filing Date
EP85104160A Expired - Lifetime EP0161471B1 (fr) 1984-04-06 1985-04-04 Récipient pour fluide contenant du bicarbonate

Country Status (9)

Country Link
US (1) US4630727A (fr)
EP (1) EP0161471B1 (fr)
JP (1) JPH0741071B2 (fr)
AT (1) ATE59774T1 (fr)
BR (1) BR8501579A (fr)
CA (1) CA1234784A (fr)
DE (1) DE3581227D1 (fr)
ES (1) ES8700059A1 (fr)
IT (1) IT1214872B (fr)

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Cited By (4)

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Publication number Priority date Publication date Assignee Title
EP0249667A1 (fr) † 1985-12-18 1987-12-23 VEECH, Richard L. Thérapie au fluide avec des anions 1-lactate et/ou pyruvate
EP0249667B2 (fr) † 1985-12-18 2004-12-29 International Limited Btg Thérapie au fluide avec des anions 1-lactate et/ou pyruvate
DE102004039989A1 (de) * 2004-08-18 2006-03-02 Ritter Gmbh Bicarbonatbehälter mit Zweikanal-Steckverbinder zum Einmalgebrauch in Hämodialysegeräten
DE102004039989B4 (de) * 2004-08-18 2006-07-06 Ritter Gmbh Bicarbonatbehälter mit Zweikanal-Steckverbinder zum Einmalgebrauch in Hämodialysegeräten

Also Published As

Publication number Publication date
IT1214872B (it) 1990-01-18
EP0161471A3 (en) 1987-06-24
ES542004A0 (es) 1986-09-16
JPH0741071B2 (ja) 1995-05-10
BR8501579A (pt) 1985-12-03
ES8700059A1 (es) 1986-09-16
IT8485554A0 (it) 1984-04-06
DE3581227D1 (de) 1991-02-14
ATE59774T1 (de) 1991-01-15
JPS61355A (ja) 1986-01-06
EP0161471A2 (fr) 1985-11-21
US4630727A (en) 1986-12-23
CA1234784A (fr) 1988-04-05

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